MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION CATHETER; SWAN-GANZ CATHETER

Model Number 131F7J

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks was returned for evaluation.A non-edwards introducer was located on the catheter body between 81 cm and 95 cm area from the catheter tip.Catheter body was tied at 55.6cm and 65.8 cm with string.Blood was visible on catheter body.No visible damage or abnormality to the catheter body, balloon or returned syringe was observed.No error message was observed on vigilance ii monitor.The thermistor was submerged in a 37.0 c water bath and read 37.0 c on vigilance ii monitor.The thermistor circuit was continuous and there were no open or intermittent conditions.The thermistor connector was opened and no visible abnormalities were found.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 1.5 cc air by holding the balloon under water for 5 minutes.Visual examinations were performed under microscope at 10x magnification and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of blood temperature measurement issue could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.The patient¿s body temperature by can be obtained by different means and compared to the temperature obtained from the catheter.If they do not correlate to the clinician¿s satisfaction, the clinician can start the troubleshooting process or abort the attempt to obtain cardiac output.The catheter can be exchanged if desired.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.Patient parameters should correlate with the patient¿s clinical manifestations.In this case it is unknown whether any user or procedural factors may have contributed to the stated event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that the indicated blood temperature was different from the patient's body temperature and the indicated co value was inaccurate on the first day of use.Both the expected and indicated values could not be obtained.The patient was not treated based on the incorrect value.No troubleshooting was performed.No error message was displayed on the monitor.There was no occlusion, leakage or kink noted in the catheter.It is unknown if the value was affected by the patient condition.There were no patient complications reported.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8800750
• MDR Text Key: 151430989
• Report Number: 2015691-2019-02630
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 60